Catherine R. Nielsen

Practice Details

• Firm Information
  Position

  Partner

  Firm Name

  Keller and Heckman LLP
• Representative Cases & Transactions
  Cases

  Representative Matters: Assisted multiple plastics manufacturers in conducting risk assessments of non-intentionally added substances/impurities in Europe
  in the U.S., respectively
  Achieved multiple clearances of additives, polymers,
  can coatings through the successful prosecution of numerous Food Contact Notifications (FCNs) in the U.S.
  Audited the regulatory compliance of a client's products for sales into food
  drug packaging in the U.S.
  Canada, based on a review of client's
  suppliers' records, formulations,
  compliance statements
  Guided a major polymer producer in communications with FDA on changes in manufacture to a food contact substance, avoiding the need for a new FCN submission
  Counseled a major producer of a food contact polymer on its recall obligations
  strategy, in the wake of a significant leak in a processing chemical during production
  Achieved FDA regulatory compliance of a color additive for cosmetic applications under Part 74 of FDA's regulations
  Oversaw the generation of a No Significant Risk Level (NSRL) under California Proposition 65, in the absence of an Office of Environmental Health Hazard Assessment (OEHHA) level,
  evaluated compliance of resin product with Prop. 65 based on that assessment
  Conducted training seminars for clients on food contact regulations in the U.S., Europe, China, MERCOSUR,
  India